- 1. Name of the medicinal product
- 2. Qualitative and quantitative composition
- 3. Pharmaceutical form
- 4. Clinical particulars
- 4.1 Therapeutic indications
- 4.2 Posology and method of administration
- 4.3 Contraindications
- 4.4 Special warnings and precautions for use
- 4.5 Interaction with other medicinal products and other forms of interaction
- 4.6 Fertility, pregnancy and lactation
- 4.7 Effects on ability to drive and use machines
- 4.8 Undesirable effects
- 4.9 Overdose
- 5. Pharmacological properties
- 5.1 Pharmacodynamic properties
- 5.2 Pharmacokinetic properties
- 5.3 Preclinical safety data
- 6. Pharmaceutical particulars
- 6.1 List of excipients
- 6.2 Incompatibilities
- 6.3 Shelf life
- 6.4 Special precautions for storage
- 6.5 Nature and contents of container
- 6.6 Special precautions for disposal and other handling
- 7. Marketing authorisation holder
- 8. Marketing authorisation number(s)
- 9. Date of first authorisation/renewal of the authorisation
- 10. Date of revision of the text
1. Name of the medicinal product
2. Qualitative and quantitative composition
The active ingredient is Sterculia BP 62% w/w.For the full list of excipients, see section 6.1
3. Pharmaceutical form
Oral granules.White irregular shaped granules.
4. Clinical particulars
4.1 Therapeutic indications
The treatment of constipation, particularly simple or idiopathic constipation and constipation during pregnancy .Management of colostomies and ileostomies.The 'High Residue Diet' management of diverticular disease of the colon and other conditions requiring a high fibre regimen.The initiation and maintenance of bowel action after rectal and anal surgery.Administration after ingestion of sharp foreign bodies to provide a coating and reduce the possibility of intestinal damage during transit.
4.2 Posology and method of administration
PosologyAdults: 1 or 2 sachets or 1-2 heaped 5ml spoonfuls, once or twice daily after meals.Older People : As adult dose.
Paediatric populationChildren: (6-12 years): one half the above amountNORMACOL is not recommended for children under 6 years of age
Method of administrationThe granules should be placed dry on the tongue and without chewing or crushing, swallowed immediately with plenty of water or a cool drink. Prior to drinking they may also be sprinkled onto and taken with soft food such as yoghurt.
Intestinal obstruction, faecal impaction, and total atony of the colon.Known hypersensitivity to the active substances or to any of the excipients listed in section 6.1
4.4 Special warnings and precautions for use
Caution should be exercised in cases of ulcerative colitis. Patients with rare hereditary problems of fructose intolerance, glucose galactose malabsorption or sucrase-isomaltase insufficiency should not take this medicine.Not to be taken immediately before going to bed or in a recumbent position especially in the elderly. Not to be taken for more than 4 days if there has been no movement of the bowels.It is not unusual for stool to appear paler in colour than normal as a result of local contact with sterculia. This does not indicate anything untoward.Possible fluid and electrolyte depletion in association with diarrhoea.Take with plenty of water to reduce the risk of oesophageal obstruction.Adequate fluid intake should be maintained.
4.5 Interaction with other medicinal products and other forms of interaction
4.6 Fertility, pregnancy and lactation
NORMACOL may be recommended during pregnancyor lactation.
4.7 Effects on ability to drive and use machines
4.8 Undesirable effects
Reporting of suspected adverse reactions
Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions via Yellow Card Scheme Website: www.mhra.gov.uk/yellowcard.
|System Organ Class||Adverse Drug Reaction|
|Immune system disorders||Allergic reactions|
|Gastrointestinal disorders||Oesophageal obstruction, intestinal/colonic obstruction or impaction, abdominal distension, flatulence, diarrhoea, nausea, abdominal pain|
Intestinal obstruction is possible in overdosage particularly in combination with inadequate fluid intake. Management is as for intestinal obstruction from other causes. If there is profound diarrhoea, dehydration and electrolyte depletion may occur.
5. Pharmacological properties
5.1 Pharmacodynamic properties
Sterculia acts in the colon by forming a soft bulky stool and inducing a laxative effect.
5.2 Pharmacokinetic properties
Sterculia is not absorbed or digested in the gastrointestinal tract and its laxative action is normally effective within 12 hours of oral administration.
5.3 Preclinical safety data
There is no evidence that Sterculia has a significant systemic toxicity potential .
6. Pharmaceutical particulars
6.1 List of excipients
Sodium hydrogen carbonateSucrose Talc Hard paraffin Titanium dioxide Vanillin
6.3 Shelf life
Sachet and lined carton: 2 years
6.4 Special precautions for storage
Store in a dry place below 25°C.
6.5 Nature and contents of container
Sachet containing 7 g of white granules in boxes of 2, 7, 30 or 60 sachets.Lined box of 100 g or 500 g of white granules.Not all pack sizes may be marketed
6.6 Special precautions for disposal and other handling
7. Marketing authorisation holder
Norgine LimitedNorgine HouseWidewater PlaceMoorhall RoadHarefieldUXBRIDGEMiddlesex UB9 6NSUnited Kingdom
8. Marketing authorisation number(s)
9. Date of first authorisation/renewal of the authorisation
10. Date of revision of the text
Norgine House, Widewater Place, Moorhall Road, Harefield, Middlesex, UB9 6NS
+44 (0)1895 825 865
Medical Information e-mail
+44 (0)1895 826 600